Tretinoin Side Effects

It is possible that some side effects of tretinoin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tretinoin: oral capsule liquid filled

As well as its needed effects, tretinoin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tretinoin, check with your doctor immediately:

More common

Black, tarry stools

bleeding

blistering

bloody stools

bone pain

burning

coldness

difficulty in moving

discomfort or pain in chest

enlarged heart

feeling of pressure

fever

hives

infection

inflammation

joint pain

lumps

numbness

paleness of skin

rash

redness

scaring

seizures

shortness of breath, troubled breathing, tightness in chest, or wheezing

soreness

stinging

sweating increased

swelling

swollen joints

tenderness

tingling

ulceration

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

warmness at site

weight gain (occurring together with any of the other symptoms listed before)

Less common

Blue lips and fingernails

convulsions (seizures)

difficulty in speaking, slow speech, or inability to speak

faintness

feeling of heaviness in chest

headache (severe)

inability to move arms, legs, or muscles of the face

nausea and vomiting (occurring together with a headache)

no blood pressure or pulse

pain in back or left arm

painful, red lumps under the skin, mostly on the legs

prominent superficial veins over affected area

stopping of heart

unconsciousness

vision problems (occurring together with a headache)

warmth

If any of the following side effects occur while taking tretinoin, check with your doctor or nurse as soon as possible:

More common

Any change in vision (not occurring with a headache)

coughing, sneezing, sore throat, and stuffy or runny nose

cracked lips

crusting, redness, pain, or sores in mouth or nose

decreased urination

earache or feeling of fullness in the ear

increase or decrease in blood pressure

irregular heartbeat

mental depression

pain in stomach, side, abdomen or back

pain and swelling in leg or foot

skin rash

swelling of abdomen (stomach area)

swelling of face, fingers, hands, feet, or lower legs

Less common

Bone swelling

cramping or pain in stomach (severe)

difficult or painful urination

drowsiness (very severe and continuing)

hallucinations (seeing, hearing, or feeling things that are not there)

hearing loss

heartburn, indigestion, or nausea (severe and continuing)

mood, mental, or personality changes

pain in lower back or side

swollen area that feels sore and tender

yellow eyes or skin

Some tretinoin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common

Acid or sour stomach

agitation

anxiety

belching

blurred vision

bloating

burning, crawling, or tingling feeling in the skin

chills

confusion

constipation

darkened urine

diarrhea

dizziness

dryness of skin, mouth, or nose

fast heartbeat

flushing

general feeling of discomfort or illness

hair loss

headache (mild and not occurring together with other side effects)

indigestion

irritability

itching of skin

loss of appetite

mood or mental changes

muscle pain

nausea and vomiting (not occurring together with a headache)

shivering

trouble sleeping

weakness

weight loss

Less common

Anxiety and restlessness (occurring together)

clumsiness or unsteadiness when walking

difficulty sleeping

disorientation

forgetfulness

frequent urination

lethargy

lightheadedness

low body temperature

redness, soreness or itching skin

sores, welting or blisters

sores on genitals

swelling of feet or lower legs

thirst

trembling, sometimes with a flapping movement

weak or feeble pulse

weakness in legs

For Healthcare Professionals

Applies to tretinoin: compounding powder, oral capsule

General

Headache, fever, weakness, and fatigue are seldom permanent and will not usually require any interruption in therapy.[Ref]

Other

Other side effects include a retinoic-acid-APL (RA-APL) syndrome characterized by fever, dyspnea, weight gain, radiographic pulmonary infiltrates and pleural or pericardial effusions, which has been reported in approximately 25% of patients treated with tretinoin. Impaired myocardial contractility and episodic hypotension have been reported occasionally with this syndrome. Several fatalities have been reported due to multiorgan failure.

Pseudotumor cerebri has also been reported. Side effects including isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, and hypercalcemia have been reported rarely.[Ref]

Due to progressive hypoxia which can occur with RA-APL syndrome, endotracheal intubation and mechanical ventilation have been required in some cases.

High dose steroids (dexamethasone 10 mg intravenously administered every twelve hours for three days or until the resolution of symptoms) given at the first signs suggestive of the RA-APL syndrome (unexplained fever, dyspnea, and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities) have been reported to appear to reduce morbidity and mortality. High dose steroids should be initiated immediately regardless of the leukocyte count. However, most patients do not require discontinuation of tretinoin therapy during treatment of the RA-APL syndrome.

Approximately 40% of patients develop a rapidly evolving leukocytosis. Rapidly evolving leukocytosis has been associated with a higher risk of life-threatening complications.

Early signs of pseudotumor cerebri have been reported to include papilledema, headache, nausea, vomiting, and visual disturbances.[Ref]

Hematologic

Hematologic side effects including a reversible hypercholesterolemia and/or hypertriglyceridemia (up to 60%), rapidly evolving leukocytosis (40%), and disseminated intravascular coagulation (26%) have been reported. Several cases of thrombocytosis have also been reported.[Ref]

Rapidly evolving leukocytosis has been associated with a higher risk of life-threatening complications.

Although hypercholesterolemia and/or hypertriglyceridemia have been reversible upon the completion of treatment, venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for these complications.[Ref]

Hepatic

Liver function tests should be monitored closely during treatment. Temporary discontinuation of therapy may be appropriate if liver test results reach greater than five times the upper limit of normal values.[Ref]

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